Clinicians, engineers, and medical care providers cite medication infusion pumps among the most problematic medical devices used today in the clinical setting. According to the US Food and Drug Administration (FDA), the problems with these devices stem from poor software design/implementation and human factor considerations, among others. "From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. During this time period, 87 infusion pump recalls were conducted by firms to address identified safety concerns."(1) A key shortcoming of current infusion pumps, based upon device error reports, is the poor human-machine interface. Clinicians often find themselves adapting their workflow to the designs of the infusion pump, as opposed to having the machines designed to clinician needs/workflow. This is largely due to the limited pre- production usability testing and human/systems factors engineering in the design of infusion pumps. In response to this, The Johns Hopkins University Applied Physics Laboratory (JHU/APL) and the Johns Hopkins Medicine (JHM) are collaborating to use simulation environments as a forum to explore innovative technical solutions to improve the safety associated with medication infusion pumps used in clinical settings. Our specific aims are to: (1) Define clinician requirements in use of medication infusion pumps and develop measures of effectiveness (MOE) and performance (MOP), (2) Develop a rapid prototype environment to test the safety/usability of simulated infusion pumps and develop medication infusion pump prototypes based upon clinician requirements, using systems engineering best practices, and (3) Measure the safety/usability profile of infusion pumps, using high-fidelity simulation. Our method and approach follows systems engineering best practices to accomplish these aims with an objective of producing performance-driven requirements for improved medical device safety. This approach will yield rapid prototyping test tools (hardware and software in the form of flexible, working pump mockups) that may be re- used by any organization seeking to improve pump design. PUBLIC HEALTH RELEVANCE: To improve the safety of medication infusion pumps, we propose conducting safety and usability testing of software-based simulations of prototype pump designs in a medical simulation center. We propose following systems engineering best practices to elicit requirements from clinicians to understand usability and safety issues with today's pump designs and to design and to implement enhancements in simulated pumps to address these usability and safety challenges. Conducting testing under controlled conditions in a medical simulation center allows us to explore safety and usability over a range of simulated scenarios not possible to achieve in a real world setting.